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Dexmedetomidine Sedation With Third Molar Surgery

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ClinicalTrials.gov Identifier: NCT01017237
Recruitment Status : Terminated (Protocol proved to be ineffective for adequate sedation for third molar surgery.)
First Posted : November 20, 2009
Results First Posted : June 17, 2013
Last Update Posted : June 17, 2013
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Anesthesia
Interventions Drug: Dexmedetomidine
Drug: Midazolam
Drug: Ketamine
Enrollment 18
Recruitment Details Patients requiring extraction of third molars requiring sedation in the Oral Surgery clinic recruited.
Pre-assignment Details  
Arm/Group Title Dex Plus Midazolam Dex Plus Midazolam and Ketamine
Hide Arm/Group Description

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam.

Period Title: Overall Study
Started 10 8
Completed 5 6
Not Completed 5 2
Arm/Group Title Dex Plus Midazolam Dex Plus Midazolam and Ketamine Total
Hide Arm/Group Description

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam.

Total of all reporting groups
Overall Number of Baseline Participants 10 8 18
Hide Baseline Analysis Population Description
Total of 5 Dex plus midazolam subjects and 2 of 8 Dex plus midazolam plus ketamine sujects were disqualified and the protocol aborted due to lack of effect and uncooperative behavior requiring use of additional sedative agents
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 8 participants 18 participants
19  (3.6) 20  (4.1) 19  (3.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 8 participants 18 participants
Female
7
  70.0%
5
  62.5%
12
  66.7%
Male
3
  30.0%
3
  37.5%
6
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 8 participants 18 participants
10 8 18
1.Primary Outcome
Title Amnesia: Lack of Picture Recall Shown Prior to Sedation.
Hide Description Subjects were shown pictures of familiar objects prior to sedation, after the bolus dose of dexmedetomidine was administered, at 15 minutes and 30 minutes into the surgery and at the end of surgery. Subjects were shown a page containing multiple pictures to evaluate whether they could remember any of them. No recall demonstrating the presence of amnesia during that portion of the procedure. This process was repeated the day following surgery
Time Frame Day of surgery prior to discharge
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized per protocol
Arm/Group Title Dexmedetomidine Plus Midazolam Dexmedetomidine Plus Midazolam and Ketamine
Hide Arm/Group Description:

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam.

Overall Number of Participants Analyzed 5 6
Measure Type: Number
Unit of Measure: percentage of participants
0 0
2.Primary Outcome
Title Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown Prior to Sedation.
Hide Description Lack of recall of picture shown indicates presence of amnesia the day following surgery.
Time Frame One day after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol
Arm/Group Title Dexmedetomidine Plus Midazolam Dexmedetomidine Plus Midazolam and Ketamine
Hide Arm/Group Description:

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam.

Overall Number of Participants Analyzed 5 6
Measure Type: Number
Unit of Measure: percentage of patients
0 0
3.Primary Outcome
Title Amnesia: Lack of Picture Recall Following Dexmedetomidine Infusion Plus Midazolam.
Hide Description Percentage of patients unable to recall picture
Time Frame Day of Surgery prior to discharge
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol
Arm/Group Title Dexmedetomidine Plus Midazolam Dexmedetomidine Plus Midazolam and Ketamine
Hide Arm/Group Description:

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam.

Overall Number of Participants Analyzed 5 6
Measure Type: Number
Unit of Measure: percentage of patients
100 100
4.Primary Outcome
Title Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown Following Dexmedetomidine Infusion Plus Midazolam.
Hide Description Inability to recall picture shown at this time indicates presence of amnesia on the day following surgery.
Time Frame One day after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Dexmedetomidine Plus Midazolam Dexmedetomidine Plus Midazolam and Ketamine
Hide Arm/Group Description:

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam.

Overall Number of Participants Analyzed 5 6
Measure Type: Number
Unit of Measure: percentage of patients
100 100
5.Primary Outcome
Title Amnesia: Lack of Picture Recall Shown 15 Minutes Into Surgery
Hide Description Lack of recall of picture shown at this time indicates presence of amnesia
Time Frame Day of Surgery prior to discharge
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Dexmedetomidine Plus Midazolam Dexmedetomidine Plus Midazolam and Ketamine
Hide Arm/Group Description:

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam.

Overall Number of Participants Analyzed 5 6
Measure Type: Number
Unit of Measure: percentage of patients
100 100
6.Primary Outcome
Title Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown 15 Minutes Into Surgery.
Hide Description Lack of recall of picture demonstrates presence of amnesia on day following surgery
Time Frame One day after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Dexmedetomidine Plus Midazolam Dexmedetomidine Plus Midazolam and Ketamine
Hide Arm/Group Description:

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam.

Overall Number of Participants Analyzed 5 6
Measure Type: Number
Unit of Measure: percentage of patients
100 100
7.Primary Outcome
Title Amnesia: Lack of Picture Recall Shown 30 Minutes Into Surgery
Hide Description Lack of recall of picture shown indicates presence of amnesia
Time Frame Day of Surgery prior to discharge
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Dexmedetomidine Plus Midazolam Dexmedetomidine Plus Midazolam and Ketamine
Hide Arm/Group Description:

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam.

Overall Number of Participants Analyzed 5 6
Measure Type: Number
Unit of Measure: percentage of patients
83 100
8.Primary Outcome
Title Primary Title: Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown 30 Minutes Into Surgery.
Hide Description Lack of recall of picture shown indicates presence of amnesia on day following surgery.
Time Frame One day after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol
Arm/Group Title Dexmedetomidine Plus Midazolam Dexmedetomidine Plus Midazolam and Ketamine
Hide Arm/Group Description:

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam.

Overall Number of Participants Analyzed 5 6
Measure Type: Number
Unit of Measure: percentage of patients
83 100
9.Primary Outcome
Title Amnesia: Lack of Picture Recall at Surgery End Time.
Hide Description Lack of recall of picture shown indicates presence of amnesia
Time Frame Day of surgery prior to discharge
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Dexmedetomidine Plus Midazolam Dexmedetomidine Plus Midazolam and Ketamine
Hide Arm/Group Description:

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam.

Overall Number of Participants Analyzed 5 6
Measure Type: Number
Unit of Measure: percentage of patients
83 100
10.Primary Outcome
Title Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown at Surgery End Time.
Hide Description Lack of recall of picture shown indicates presence of amnesia on day following surgery.
Time Frame One day after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Dexmedetomidine Plus Midazolam Dexmedetomidine Plus Midazolam and Ketamine
Hide Arm/Group Description:

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam.

Overall Number of Participants Analyzed 5 6
Measure Type: Number
Unit of Measure: percentage of patients
83 100
11.Secondary Outcome
Title Respiratory Parameters: Respiratory Rate
Hide Description Respirations per minute
Time Frame Immediately prior to sedation
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized per protocol
Arm/Group Title Dex Plus Midazolam Dex Plus Midazolam and Ketamine
Hide Arm/Group Description:

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam.

Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: Breaths per Minute
15  (3) 17.2  (4)
12.Secondary Outcome
Title Respiratory Parameters: Respiratory Rate
Hide Description Rate of respirations
Time Frame During surgical procedure
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Dex Plus Midazolam Dex Plus Midazolam and Ketamine
Hide Arm/Group Description:

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam.

Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: Breaths per Minute
15  (3) 19  (4)
13.Secondary Outcome
Title Respiratory Parameters: Oxyhemoglobin Saturation
Hide Description Oxyhemoglobin saturation per pule oximeter
Time Frame Immediately prior to surgery
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Dex Plus Midazolam Dex Plus Midazolam and Ketamine
Hide Arm/Group Description:
Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam.

Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: Percent oxyhemoglobin saturation
98  (2.5) 98  (2.4)
14.Secondary Outcome
Title Respiratory Parameters: Oxyhemoglobin Saturation
Hide Description Oxyhemoglobin saturation per pulse oximetry
Time Frame During surgical procedure
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Dex Plus Midazolam Dex Plus Midazolam and Ketamine
Hide Arm/Group Description:
Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam.

Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: Percent oxyhemoglobin saturation
98  (2.5) 98  (3.4)
15.Secondary Outcome
Title Respiratory Parameters: End-tidal Carbon Dioxide
Hide Description Measured via capnography at nares
Time Frame Immediately prior to sedation
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Dex Plus Midazolam Dex Plus Midazolam and Ketamine
Hide Arm/Group Description:
Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam.

Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: mmHg
39.4  (4.7) 36.2  (5.3)
16.Secondary Outcome
Title Respiratory Parameters: End-tidal Carbon Dioxide
Hide Description Measured by capnography at nares
Time Frame Duration of surgery
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per protocol
Arm/Group Title Dex Plus Midazolam Dex Plus Midazolam and Ketamine
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Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam.

Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: mmHg
36.9  (5.1) 38.2  (4.76)
17.Secondary Outcome
Title Mean Arterial Blood Pressure
Hide Description Blood pressure per automated monitor
Time Frame Immediately prior to surgery
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per protocol
Arm/Group Title Dex Plus Midazolam Dex Plus Midazolam and Ketamine
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Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam.

Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: mmHg
96.2  (12.4) 96.4  (15.3)
18.Secondary Outcome
Title Mean Arterial Blood Pressure
Hide Description Measured using automated blood pressure monitor
Time Frame During duration of surgery
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Hide Analysis Population Description
per protocol
Arm/Group Title Dex Plus Midazolam Dex Plus Midazolam and Ketamine
Hide Arm/Group Description:
Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam.

Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: mmHg
93.8  (21.2) 95.9  (18.9)
19.Secondary Outcome
Title Heart Rate
Hide Description Heart rate per EKG monitor
Time Frame Prior to sedation
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Hide Analysis Population Description
per protocol
Arm/Group Title Dex Plus Midazolam Dex Plus Midazolam and Ketamine
Hide Arm/Group Description:
Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam.

Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: Beats per minute
66.8  (11.2) 71.4  (18.4)
20.Secondary Outcome
Title Heart Rate
Hide Description Per EKG monitor
Time Frame Duration of surgery
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per protocol
Arm/Group Title Dex Plus Midazolam Dex Plus Midazolam and Ketamine
Hide Arm/Group Description:
Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam.

Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: Beats per minute
75  (12.4) 85.6  (15.1)
21.Secondary Outcome
Title Surgeon Satisfaction With Sedation Technique
Hide Description Numerical value on scale of 1-5 from Very dissatisfied (1) to Extremely satisfied (5)
Time Frame After surgery completed: day of surgery, within 15 minutes
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per protocol
Arm/Group Title Dex Plus Midazolam Dex Plus Midazolam and Ketamine
Hide Arm/Group Description:

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam.

Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.0  (0.4) 3.2  (0.6)
22.Secondary Outcome
Title Patient Satisfaction With Sedation Technique
Hide Description Rating of how satisfied the patient was with their sedation on a scale of 1-5 with 1 being very dissatisfied and 5 being extremely satisfied
Time Frame after completion of surgery (within 15 minutes)
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per protocol
Arm/Group Title Dex Plus Midazolam Dex Plus Midazolam and Ketamine
Hide Arm/Group Description:

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam.

Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.7  (0.2) 4.8  (0.2)
23.Secondary Outcome
Title Ramsey Sedation Scale Score
Hide Description Rating of depth of sedation by sedationist. Scale 1 - 6, 1 being widw awake and 6 being non-responsive
Time Frame During surgical procedure
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per protocol
Arm/Group Title Dex Plus Midazolam Dex Plus Midazolam and Ketamine
Hide Arm/Group Description:
Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam.

Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.2  (0.4) 3.5  (0.5)
24.Secondary Outcome
Title Bispectral Index Score (BIS)
Hide Description Bispectral Index (BIS) measures level of consciousness by algorithmic analysis of the patient's electroencephalogram (EEG) during anesthesia and sedation. The BIS can range from 0 (equivalent to EEG silence) to 100 (equivalent to fully awake and alert). A BIS value of 40-60 indicates an adequate general anesthesia state.
Time Frame During surgery duration.
Hide Outcome Measure Data
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per protocol
Arm/Group Title Dex Plus Midazolam Dex Plus Midazolam and Ketamine
Hide Arm/Group Description:
Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam.

Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: units on a scale
75.1  (11.2) 82.6  (12.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dex Plus Midazolam Dex Plus Midazolam and Ketamine
Hide Arm/Group Description

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.

Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam.

All-Cause Mortality
Dex Plus Midazolam Dex Plus Midazolam and Ketamine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dex Plus Midazolam Dex Plus Midazolam and Ketamine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dex Plus Midazolam Dex Plus Midazolam and Ketamine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/8 (0.00%) 
Early termination due to ineffective sedation. We had to abandon the protocol in 5 of 10 patients in the dexmedetomidine plus midazolam group and 2 of 8 patients in the dexmedetomidine plus midazolam and ketamine group because of combative behavior.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jay Anderson, DDS, MD
Organization: University of North Carolina School of Dentistry
Phone: 919-966-1126
EMail: janderson@aims.unc.edu
Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01017237     History of Changes
Other Study ID Numbers: 08-2157
First Submitted: August 14, 2009
First Posted: November 20, 2009
Results First Submitted: January 31, 2013
Results First Posted: June 17, 2013
Last Update Posted: June 17, 2013